Feasibility Study on LITT for Newly Diagnosed Glioblastoma

NCT ID: NCT02880410

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-09-14

Brief Summary

Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LITT Treatment w/radiation therapy and temozolomide

This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide

Group Type: EXPERIMENTAL

NeuroBlate System

Intervention Type: DEVICE

Laser Interstitial Thermal Therapy

Radiation therapy and temozolomide

Intervention Type: DRUG

Radiation therapy and temozolomide

Interventions

NeuroBlate System

Laser Interstitial Thermal Therapy

Intervention Type: DEVICE

Radiation therapy and temozolomide

Radiation therapy and temozolomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy

2. Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)

3. The patient must be ≥18 years of age

4. KPS > 70

5. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.

6. Stable cardiovascular, pulmonary health status

Exclusion Criteria

1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs

2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant

3. Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage

4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements

5. Pregnancy, or planning to become pregnant

6. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects

7. Patients with multiple or multifocal GBM

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monteris Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manmeet Ahluwalia, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Sujit Prabhu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Washington University

St Louis, Missouri, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

FLAG

Identifier Type: -

Identifier Source: org_study_id